Study Summary
This is a single arm, open-label, multi-center, phase I study to evaluate the safety, tolerability, preliminary efficacy, pharmacodynamics and immunogenicity of universal chimeric natural killer receptor modified T-cells (CNK-UT) targeting NKG2D-Ligands and NCR2-Ligands with or without lymphodepletion in advanced solid tumors.
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Universal Chimeric Natural Killer Receptor Modified T-cells (CNK-UT)BIOLOGICAL
1. Dose Escalation: After enrollment, participants will recieve preconditioning by lymphodepletion or not, and then will be treated with CNK-UT cells with a "3 +3" design to determine the maximum tolerated dose. 3 dose level of CNK-UK cells will be tested: 4.6E6/kg,1.5E7/kg,4.6E7/kg. The participants will first receive a single ascending dose(SAD) mode of administration. During the DLT observation period (21 days), if the participants do not experience DLT, they will receive a multiple ascending dose(MAD) mode of administration.
2. Indications Expansion: It will be carried out after all participants have completed the DLT observation in the Dose Escalation phase. The target population, dosage and frequency of drug administration in the indication expansion stage can be adjusted and determined according to the previous research results.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| First affiliated hospital, School of Medicine, Zhejiang University | Hangzhou | China |